I first covered hairy skin regeneration company PolarityTE (PTE) in 2017. I did not update their work for two years as their were some concerns. However, it seems like the company is still active and holds potential. So it is time for an update.
Update: June 2021
SkinTE Biologics License Application
PolarityTE plans to file for a Biologics License Application (BLA) for SkinTE in the second half of 2021. In the meantime, the company will (temporarily) cease sales of SkinTE and wind down commercial operations.
Note that this issue is related to the US FDA’s recent announcement that enforcement discretion related to 361 HCT/P products will not be extended beyond May 31, 2021. A development that has also adversely impacted the marketing and use of exosomes in hair loss patients.
Despite a limited team of just eight sales agents, PolarityTE reported record SkinTE sales of $1.73 million in the first quarter of 2021. Per CEO David Seaburg, the company will still try to help physicians who are treating severe wounds in patients through compassionate use programs. Possibility via the FDA’s Expanded Access IND program.
So all in all, it seems like SkinTE is at least a modest success. Future sales will depend on the BLA approval. Note that in May 2021, PolarityTE announced positive results in initial trials of using SkinTE to treat diabetic foot ulcers.
May 1, 2019
My past posts on skin regeneration company PolarityTE are worth a reread for background information. The only reason I keep covering this Utah-based company is because the new skin they claim to be able to regenerate includes new hair follicles. The company is also led by some highly reputable and experienced scientists.
In the past, PolarityTE even had a photo of a balding man on their site getting treatment on his scalp. Although this photo has since disappeared, we all hope that the company can regrow scalp hair by regrowing scalp skin.
PolarityTE and Hair Follicles
In March, scientists from PolarityTE in collaboration with others published an important new study: In vivo expansion and regeneration of full‐thickness functional skin. The below caught my eye:
Moreover, in a recent Australian radio interview, PolarityTE’s (now ex) CEO Dr. Denver Lough said the following:
All of this is very encouraging. Skin regeneration is a far greater area of research than hair regeneration, since burn and accident victims can become irreparably disfigured.